Events

Retiro De Equipo (Recall) de Nephros SafeShower

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Nephros Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    66736
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0488-2014
  • Fecha de inicio del evento
    2013-10-28
  • Fecha de publicación del evento
    2013-12-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123218
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Nephros SafeShower - Product Code ND
  • Causa
    Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
  • Acción
    Nephros sent an Urgent Medical Device Recall letter dated October 28, 2013, with a return response form to all affected customers via UPS 2nd Day Air. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease shipment of the affected product immediately. Obtain an RGA number to return the new and used filters for credit. In addition, customers were instructed to immediately remove and discard all copies of the labeling materials that pertain to the affected product. Remove all electronic copies of these materials from any publicly accessible locations (e.g. website). Customers with questions were instructed to contact their Nephros representative or call 201-343-5202, ext 100. For questions regarding this recall call 201-343-5202. The letter was also posted at: http://www.nephros.com/download/news/SafeSpout_SafeShower_Recall_Letters.pdf Nephros sent a new recall letter dated 2/20/204 as they determined they have additional customers.

Device

Nephros SafeShower
  • Modelo / Serial
    Item Number 70-0236 and 70-0237 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 || 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 || Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 || Assembled at MEDICA 41036 Medolla, Italy || The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose
  • Manufacturer
    Nephros Inc

Manufacturer

Nephros Inc
  • Dirección del fabricante
    Nephros Inc, 41 Grand Ave, River Edge NJ 07661-1947
  • Empresa matriz del fabricante (2017)
    Nephros, Inc.
  • Source
    USFDA